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Study to Evaluate the Safety and Pharmacokinetics of Single Doses of ASP2151 in Healthy Male Subjects and the Effects of Food

Primary Purpose

Herpes Genitalis, Herpes Zoster

Status

Completed

Phase

Phase 1

Locations

France

Study Type

Interventional

Intervention

ASP2151

Placebo

About this trial

This is an interventional basic science trial for Herpes Genitalis focused on measuring Safety of ASP2151, Phase 1, Pharmacokinetics, Healthy male subjects, Tolerability, Food effect of ASP2151

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Body weight between 60 and 100 kg, and BMI between 18 and 30 kg/m2 inclusive

Exclusion Criteria:

Known or suspected hypersensitivity to ASP2151 or any components of the formulation used
Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug
Any clinically significant history of genital herpes symptoms and/or herpes zoster symptoms in the 3 months prior to admission to the Clinical Unit
Any clinically significant history of any other disease or disorder - gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic
Abnormal pulse rate and/or blood pressure measurements at the pre-study visit as follows: Pulse rate <40 or >90 bpm (beats per minute); mean systolic blood pressure <90 or >140 mmHg (millimeter of mercury); mean diastolic blood pressure <40 or >95 mmHg
Regular use of any prescribed or OTC (over the counter) drugs in the 4 weeks prior to admission to the Clinical Unit OR any use of such drugs in the 2 weeks prior to admission to the Clinical Unit
Any use of drugs of abuse within 3 months prior to admission to the Clinical Unit
History of smoking more than 10 cigarettes per day within 3 months prior to admission to the Clinical Unit
History of drinking more than 21 units of alcohol per week within 3 months prior to admission to the Clinical Unit
Donation of blood or blood products within 3 months, prior to admission to the Clinical Unit
Positive serology test for HBsAg (Hepatitis B surface antigen), HAV IgM (Hepatitis A Virus), anti-HCV (Hepatitis C Virus) or anti-HIV (Human Immunodeficiency Virus) 1 and 2
Not willing or able to swallow size 00 capsules

Sites / Locations

Site FR1717

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Part 1: ASP2151 Single Ascending Dose Group A (Fasting)

Part 1: ASP2151 Single Ascending Dose Group B (Fasting)

Part 1: ASP2151 Single Ascending Dose Group C (Fasting)

Part 1: ASP2151 Single Ascending Dose Group D (Fasting)

Part 1: ASP2151 Single Ascending Dose Group E (Fasting)

Part 1: ASP2151 Single Ascending Dose Group F (Fasting)

Part 1: Placebo Single Ascending Dose (Fasting)

Part 2: ASP2151 (Fasting)

Part 2: ASP2151 (Fed)

Part 1: ASP2151 Single Ascending Dose Group G (Fasting)

Part 1: ASP2151 Single Ascending Dose Group H (Fasting)

Arm Description

Participants will receive single dose of ASP2151 assigned to Group A on day 1

Participants will receive single dose of ASP2151 assigned to Group B on day 1

Participants will receive single dose of ASP2151 assigned to Group C on day 1

Participants will receive single dose of ASP2151 assigned to Group D on day 1

Participants will receive single dose of ASP2151 assigned to Group E on day 1

Participants will receive single dose of ASP2151 assigned to Group F on day 1

Participants will receive single dose of matching placebo on day 1

Participants will receive a single dose of ASP2151 under fasted conditions on day 1 in the first treatment period (period 1). Following a wash-out period of at least five days, the treatment will be repeated in the reverse orientation (period 2)

Participants will receive a single dose of ASP2151 under fed conditions on day 1 in the first treatment period (period 1). Following a wash-out period of at least five days, the treatment will be repeated in the reverse orientation (period 2)

Participants will receive single dose of ASP2151 assigned to Group G on day 1

Participants will receive single dose of ASP2151 assigned to Group H on day 1

Outcomes

Primary Outcome Measures

Safety and tolerability assessed by nature, frequency, and severity of Adverse Events (AEs)

For Part 1 and Part 2

Safety assessed by 12- lead electrocardiogram (ECG)

For Part 1 and Part 2

Safety assessed by vital sign measurement: blood pressure

For Part 1 and Part 2 includes systolic and blood diastolic pressure

Safety assessed by vital sign measurement: pulse rate

For Part 1 and Part 2

Safety assessed by laboratory test: biochemical

For Part 1 and Part 2

Safety assessed by laboratory test: hematological

For Part 1 and Part 2

Safety assessed by laboratory test: serology

For Part 1 and Part 2

Safety assessed by laboratory test: urinalysis

For Part 1 and Part 2

Safety assessed by physical exam: body weight

For Part 1 and Part 2

Safety assessed by physical exam: height

For Part 1 and Part 2

Safety assessed by physical exam: body mass index (BMI)

For Part 1 and Part 2

Secondary Outcome Measures

Pharmacokinetics of ASP2151 in plasma: AUC0-inf

For Part 1 and 2. AUC0-inf: Area under the concentration time curve from the time of dosing extrapolated to time infinity

Pharmacokinetics of ASP2151 in plasma: t1/2

For Part 1 and 2. t1/2: Apparent terminal elimination half-life

Pharmacokinetics of ASP2151 in plasma: Cmax

For Part 1 and 2. Cmax: Maximum concentration

Pharmacokinetics of ASP2151 in plasma: tmax

For Part 1 and 2. tmax: The time after dosing when Cmax occurs

Pharmacokinetics of ASP2151 in plasma: CL/F

For Part 1 and 2. CL/F: Oral clearance

Pharmacokinetics of ASP2151 in plasma: Vz/F

For Part 1 and 2. Vz/F: Apparent volume of distribution

Pharmacokinetics of ASP2151 in plasma: AUClast

For Part 1 and 2. AUClast: Area under the plasma concentration time curve from time of dosing up to the last quantifiable sample

Pharmacokinetics of ASP2151 in plasma: tlag

For Part 1 and 2. tlag: Absorption lag time

Pharmacokinetics of ASP2151 in urine: Aelast

For Part 1 and 2. Aelast: Amount excreted unchanged in urine from time of dosing up to the last quantifiable sample

Pharmacokinetics of ASP2151 in urine: Ae0-inf

For Part 1 and 2. Ae0-inf: Amount excreted unchanged in urine from time of dosing extrapolated to infinity

Pharmacokinetics of ASP2151 in urine: Ae%

For Part 1 and 2. Ae%: Percent of ASP2151 amount excreted in urine

Pharmacokinetics of ASP2151 in urine: CLr

For Part 1 and 2. CLr: Renal clearance

Full Information

NCT ID

NCT02852876

First Posted

July 29, 2016

Last Updated

July 29, 2016

Sponsor

Astellas Pharma Europe Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02852876

Brief Title

Study to Evaluate the Safety and Pharmacokinetics of Single Doses of ASP2151 in Healthy Male Subjects and the Effects of Food

Official Title

A Double-Blind, Placebo-Controlled Single Dose Escalating Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP2151 in Healthy Male Subjects, Followed by an Open, Two-Period Crossover Study to Assess the Effect of Fed Conditions on the Safety, Tolerability and Pharmacokinetics of ASP2151

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

December 2005 (Actual)

Study Completion Date

December 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Astellas Pharma Europe Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The objective of this study is to evaluate the safety and tolerability of single rising doses of ASP2151 under fasted condition in healthy male subjects. The study will also evaluate the pharmacokinetics (PK) of a single dose of ASP2151 under fasted versus fed conditions in healthy male subjects.

Detailed Description

Study will be divided into two parts. Part 1 will evaluate the safety and tolerability of ASP2151 single rising doses in groups A-H in fasted condition and to determine the maximum tolerable dose (MTD) if possible. Part 2 will evaluate the effect of fasted versus fed conditions on the safety, tolerability and PK of a single dose of ASP2151 in two treatment cycles. The wash-out period between the two treatment cycles will be at least 5 days and not shorter than five times the average elimination half-life of ASP2151, as determined in part 1 of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Herpes Genitalis, Herpes Zoster

Keywords

Safety of ASP2151, Phase 1, Pharmacokinetics, Healthy male subjects, Tolerability, Food effect of ASP2151

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part 1: ASP2151 Single Ascending Dose Group A (Fasting)

Arm Type

Experimental

Arm Description

Participants will receive single dose of ASP2151 assigned to Group A on day 1

Arm Title

Part 1: ASP2151 Single Ascending Dose Group B (Fasting)

Arm Type

Experimental

Arm Description

Participants will receive single dose of ASP2151 assigned to Group B on day 1

Arm Title

Part 1: ASP2151 Single Ascending Dose Group C (Fasting)

Arm Type

Experimental

Arm Description

Participants will receive single dose of ASP2151 assigned to Group C on day 1

Arm Title

Part 1: ASP2151 Single Ascending Dose Group D (Fasting)

Arm Type

Experimental

Arm Description

Participants will receive single dose of ASP2151 assigned to Group D on day 1

Arm Title

Part 1: ASP2151 Single Ascending Dose Group E (Fasting)

Arm Type

Experimental

Arm Description

Participants will receive single dose of ASP2151 assigned to Group E on day 1

Arm Title

Part 1: ASP2151 Single Ascending Dose Group F (Fasting)

Arm Type

Experimental

Arm Description

Participants will receive single dose of ASP2151 assigned to Group F on day 1

Arm Title

Part 1: Placebo Single Ascending Dose (Fasting)

Arm Type

Placebo Comparator

Arm Description

Participants will receive single dose of matching placebo on day 1

Arm Title

Part 2: ASP2151 (Fasting)

Arm Type

Experimental

Arm Description

Arm Title

Part 2: ASP2151 (Fed)

Arm Type

Experimental

Arm Description

Arm Title

Part 1: ASP2151 Single Ascending Dose Group G (Fasting)

Arm Type

Experimental

Arm Description

Participants will receive single dose of ASP2151 assigned to Group G on day 1

Arm Title

Part 1: ASP2151 Single Ascending Dose Group H (Fasting)

Arm Type

Experimental

Arm Description

Participants will receive single dose of ASP2151 assigned to Group H on day 1

Intervention Type

Drug

Intervention Name(s)

ASP2151

Intervention Description

Oral

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral

Primary Outcome Measure Information:

Title

Safety and tolerability assessed by nature, frequency, and severity of Adverse Events (AEs)

Description

For Part 1 and Part 2

Time Frame

Up to Day 15 of each treatment period

Title

Safety assessed by 12- lead electrocardiogram (ECG)

Description

For Part 1 and Part 2

Time Frame

Up to Day 15 of each treatment period

Title

Safety assessed by vital sign measurement: blood pressure

Description

For Part 1 and Part 2 includes systolic and blood diastolic pressure

Time Frame

Up to Day 15 of each treatment period

Title

Safety assessed by vital sign measurement: pulse rate

Description

For Part 1 and Part 2

Time Frame

Up to Day 15 of each treatment period

Title

Safety assessed by laboratory test: biochemical

Description

For Part 1 and Part 2

Time Frame

Up to Day 15 of each treatment period

Title

Safety assessed by laboratory test: hematological

Description

For Part 1 and Part 2

Time Frame

Up to Day 15 of each treatment period

Title

Safety assessed by laboratory test: serology

Description

For Part 1 and Part 2

Time Frame

Up to Day 15 of each treatment period

Title

Safety assessed by laboratory test: urinalysis

Description

For Part 1 and Part 2

Time Frame

Up to Day 15 of each treatment period

Title

Safety assessed by physical exam: body weight

Description

For Part 1 and Part 2

Time Frame

Up to Day 15 of each treatment period

Title

Safety assessed by physical exam: height

Description

For Part 1 and Part 2

Time Frame

Up to Day 15 of each treatment period

Title

Safety assessed by physical exam: body mass index (BMI)

Description

For Part 1 and Part 2

Time Frame

Up to Day 15 of each treatment period

Secondary Outcome Measure Information:

Title

Pharmacokinetics of ASP2151 in plasma: AUC0-inf

Description

For Part 1 and 2. AUC0-inf: Area under the concentration time curve from the time of dosing extrapolated to time infinity

Time Frame